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Quality control
Clearly, following the appropriate quality standards is
a prerequisite to successful manufacturing. A practical
starting point is the guidelines for Good Manufacturing
Practices (GMP) issued by the US Food and Drug
Administration (FDA), which state the following:
You should determine whether:
The nature of supplies drawn from surface sources The water used as a pharmaceutical ingredient is used
can vary greatly and be subject to short term seasonal as-is (i.e., directly from the tap) or if it has been treated
changes, extreme weather conditions and the life cycle of before being used (i.e., has it been treated by such
many types of flora that might bloom for only a few months means as deionization, distillation, or reverse osmosis)
of the year; cyanobacteria, or blue/green algae, being a There are established procedures for ensuring that the
typical example, which can be difficult for conventional water used as a pharmaceutical ingredient
purification systems to eliminate. Is of a defined quality
Is not affected by materials used in the water
Maintaining consistent quality has also recently been Is being tested or monitored regularly to verify
affected by the issue of increased rainfall, which results that it meets applicable chemical, physical, and
in demands on water authorities to put in place additional microbiological quality; and
treatment programmes to deal with the massive The entire system for supplying water used as a
fluctuations in abstracted water quality. pharmaceutical ingredient is set up to avoid stagnation
and risks of contamination (This system should be
The variable condition of water supplies under these routinely cleaned and sanitised according to an
conditions and in areas of high risk can therefore make the appropriate Standard Operating Procedure (SOP) that
design of raw water treatment systems more complicated, ensures no biofilm build-up.)
as they generally need to be based on the anticipated
worst case conditions and will almost certainly require Beyond this, there may be specific quality standards
pre-treatment, including processes such as conventional and validation requirements that need to be followed,
media filtration to reduce seasonal levels of suspended and depending on the nature of the product and of your
dissolved solids. particular organisation.
Water Purification Systems
Producing purified water micron filtration. Control is normally via a front mounted
The wide variations in the chemistry of water supplies can LCD touch screen display, providing details such as water
complicate the task of conditioning raw water to remove quality, temperature and flow rates, with visual and audible
all minerals, chlorine, bacteria and other pathogens and alarms and the ability to export operating data via a USB or
suspended solids. In particular, the specification and networked connection.
installation of purification systems should be carried out
in partnership with a specialised supplier with the detailed Depending on the application, higher volume production
knowledge to ensure that systems are correctly designed operations essentially use scaled up versions of the
to maximise removal and flow rates maintain consistency, smaller water purification systems described above,
while optimising long term operating costs, with minimum perhaps supplemented by systems such as sand and
water and energy consumption. multi-media filters, for eliminating particulates, or activated
carbon adsorption systems for the removal of organic
contaminants and chlorine compounds that can affect
colour, taste and odour. Reverse osmosis is used for
the bulk of the removal of ionic or dissolved mineral
contaminants. In addition, ion exchange technology in the
form of either ion-exchange resins or Electro-deionisation
(EDI) is often used to polish the purified water up to
compliant levels, with UV and bacterial filtration commonly
being added to maintain microbiological integrity.
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